FDA Authorizes Marketing of Nicotine Pouches, a First for the Agency

The FDA authorized the marketing of 20 different Zyn nicotine pouch products — the first brand to clear this regulatory hurdle in the increasingly popular class of single-use sachets of flavored nicotine designed to be placed between the lip and gums, which have been available for more than a decade.

After the Family Smoking Prevention and Tobacco Control Act was enacted in 2009, the agency has been slowly working its way through legal challenges and scientific review hurdles for a glut of products in the premarket tobacco product application pathway. The FDA noted that it has now made determinations on more than 26 million of the nearly 27 million product applications received via this pathway.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, in a statement. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

The authorization came on the heels of FDA’s Wednesday announcement of its long-awaited proposal to drastically limit the amount of nicotine in cigarettes and some other tobacco products, with the goal of making them less addictive.

“While today’s actions permit these specific tobacco products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,'” the agency cautioned in its statement on Thursday. “There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start.”

The agency noted that its evaluation showed that the authorized Zyn products have “substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus,” and thus pose a lower risk of cancer and other serious health conditions. A study also showed that “a substantial proportion” of adult smokers or smokeless tobacco product users completely switched to nicotine pouches.

Zyn products authorized for marketing include 3- and 6-mg products with flavors such as cinnamon, citrus, coffee, menthol, and three different types of mint.

These are “flavors that clearly appeal to kids,” argued Yolonda Richardson, MPH, JD, in a statement as president and CEO of the Campaign for Tobacco-Free Kids. “The FDA’s decision is deeply troubling given the extensive scientific evidence that flavored tobacco products appeal to kids and the fact that nicotine pouches were the only category of tobacco product that saw an increase in youth use last year. The FDA is sanctioning a flavored tobacco product that is already increasing in popularity with kids and repeating the mistakes it made with Juul that resulted in the youth e-cigarette epidemic.”

She pointed to 2024 National Youth Tobacco Survey data showing an increase in the absolute number of middle and high school students reporting use of nicotine pouches, from 200,000 in 2021 (0.8%) to 480,000 (1.8%) in 2024. Zyn was reported as the most commonly used brand by teens.

A recent study in JAMA showed low overall use of nicotine pouches (2.9% ever use and 0.4% current use) among U.S. adults, but an increase of 641% in use from 2019 to 2022. Concerns about further growth in use of these products that create nicotine dependence have been raised, particularly after videos of young people popping the pouches circulated on TikTok and other social media platforms, garnering millions of views.

“It’s critical that the manufacturer market these products responsibly to prevent youth use,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the agency’s statement. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

The marketing authorizations do not extend to any other nicotine pouches or other Zyn products, the FDA noted. “Additionally, the authorization does not allow the company to make reduced risk claims about the authorized products, which would require a modified risk tobacco product application,” they added.

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